Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

American Regent

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency Anemia

Treatments: Drug: IV Iron (standard of care); Drug: Ferrous Sulfate Tablets; Drug: Ferric Carboxymaltose (FCM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00982007

1VIT09031

Details and patient eligibility

About

The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.

Enrollment: 997 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects ≥ to 18 years of age and able to give informed consent.
• Diagnosis of Iron Deficiency Anemia (IDA).
• Hemoglobin (Hgb) ≤ to 11 g/dL.
• Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.
• Must demonstrate an unsatisfactory response or intolerance to oral iron.

Exclusion criteria

• Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate.
• Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
• Requires dialysis for treatment of chronic kidney disease.
• No evidence of iron deficiency.
• Any non-viral infection.
• AST or ALT at screen 1, as determined by central labs, greater than 1.5 times the upper limit of normal.
• Known positive hepatitis with evidence of active disease.
• Received an investigational drug within 30 days of screening.
• Alcohol or drug abuse within the past 6 months.
• Hemochromatosis or other iron storage disorders.
• Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG Performance Status greater than 1.
• Any other laboratory abnormality, medical condition, or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
• Pregnant or sexually-active females who are of childbearing potential and who are not willing to use an acceptable form of contraception.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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997 participants in 4 patient groups

Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)

Experimental group

Description:

Intravenous (IV) iron

Treatment:

Drug: Ferric Carboxymaltose (FCM)

Drug: Ferric Carboxymaltose (FCM)

Cohort 1 (Group B) - Ferrous Sulfate

Active Comparator group

Description:

Oral iron - Ferrous Sulfate tablets

Treatment:

Drug: Ferrous Sulfate Tablets

Cohort 2 (Group D) - IV Iron (standard of care)

Active Comparator group

Description:

Other IV iron

Treatment:

Drug: IV Iron (standard of care)

Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)

Experimental group

Description:

Intravenous (IV) iron

Treatment:

Drug: Ferric Carboxymaltose (FCM)

Drug: Ferric Carboxymaltose (FCM)